Position: Principal Medical Writer
Location: Remote, India
Job ID: R-01332281
Job Type: Full-time
Category: Clinical Research
Work Schedule: Standard (Mon-Fri)
Environment: Office / Remote
The Clinical Research team at PPD® is part of a leading global CRO, delivering scientific and clinical expertise to advance drugs addressing complex health challenges. The team drives operational excellence across clinical study planning, documentation, and regulatory submissions.
Lead medical and scientific writing for clinical research projects. Responsible for producing high-quality documents, mentoring junior writers, providing guidance on regulatory and industry best practices, and supporting internal and external clients. Acts as a backup program manager when required.
1. Document Creation & Review
Research, write, and edit clinical study reports, study protocols, and summaries of clinical data.
Serve as primary author on complex clinical and scientific documents, including:
Investigator Brochures (IBs)
Investigational New Drug (IND) submissions
Marketing Authorization Applications (MAAs)
Review documents prepared by team members to ensure quality, accuracy, and compliance.
Provide training and guidance to junior writers on document preparation, regulatory requirements, and therapeutic area knowledge.
2. Compliance & Best Practices
Ensure all documents meet quality standards and regulatory requirements.
Develop and review best practices, methods, and techniques for efficient and compliant document development.
Lead process improvement initiatives and manage performance metrics for assigned projects.
3. Project Management & Support
Serve as backup program manager:
Develop timelines, budgets, and forecasts
Manage contract modifications
Assist business development with client proposals and presentations
Participate in bid defense and capability meetings
Represent the department in project launch, review, and team meetings.
Education & Experience
Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
Minimum 8+ years of relevant experience in medical writing.
Experience managing complex medical writing projects.
Previous pharmaceutical or CRO experience preferred.
Additional certifications (AMWA, EMWA, RAC) advantageous.
Knowledge, Skills & Abilities
Extensive knowledge of global, regional, and national document development guidelines.
Expertise in one or more areas: preclinical, therapeutic, regulatory, submissions, or communications.
Strong data interpretation and medical writing skills (grammatical, editorial, proofreading).
Advanced project management, interpersonal, oral and written communication, and presentation skills.
Excellent negotiation, decision-making, and problem-solving abilities.
Ability to mentor and lead junior staff effectively.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Frank Scottile Blvd |Missouri :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
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Cork | Dublin | Limerick | Waterford |Ulster :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | North York | Australia | Uxbridge | Renfrew | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Barcelona |Madrid :
Madrid |Cebu Province :
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Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
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Bangkok |Israel :
Yavne | Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv |Remote :
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King Abdullah Economic City | Khulais | Riyadh | Rabigh | Najran | Jeddah |Kuala Lumpur :
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Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
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